Cleared Traditional

K951101 - LEUKO-TEST (FDA 510(k) Clearance)

Class I Immunology device.

K951101 · Techlab, Inc. · Immunology device
Apr 1995
Decision
45d
Days
Class 1
Risk

K951101 is an FDA 510(k) clearance for the LEUKO-TEST. Classified as Lactoferrin, Antigen, Antiserum, Control (product code DEG), Class I - General Controls.

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on April 24, 1995 after a review of 45 days — a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5570 — the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment — the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K951101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1995
Decision Date April 24, 1995
Days to Decision 45 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
232d faster than avg
Panel avg: 277d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DEG Lactoferrin, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5570
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.